Scoliosis PatientsNCT07054411
Hemoglobin Monitoring in Scoliosis Surgery
An observational study of Scoliosis Patients, run by Erhan Ozyurt at 1 site in Turkey (Türkiye).
Trial summary
The study is planned to include patients who will undergo elective scoliosis surgery under general anesthesia at the Health Sciences University Antalya Education and Research Hospital. Demographic data including age, gender, height, weight, and ASA score of the patients will be recorded before general anesthesia. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Scoliosis Patients
- What is being tested?
- Radical-7 Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 31 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who apply to our hospital's orthopedic clinics to undergo elective scoliosis surgery.
Who may be able to join
- Preoperative hemoglobin ≥ 9 g/dL
- ASA I - III
Who cannot join
- Patients with hematological disease,
- Uncorrected preoperative anemia (preoperative hemoglobin < 9 g/dL)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Antalya Training and Research Hospital
Antalya, 07000
About this study
Official title: Hemoglobin Monitoring in Scoliosis Surgery: Comparison of Non-invasive and Invasive Methods
The study is planned to include patients who will undergo elective scoliosis surgery under general anesthesia at the Health Sciences University Antalya Education and Research Hospital. Demographic data including age, gender, height, weight, and ASA score of the patients will be recorded before general anesthesia. ECG, oxygen saturation, and non-invasive blood pressure will be monitored while the patients are lying supine before general anesthesia. An esophageal temperature probe will be placed before being placed in the prone position. All patients will receive standard anesthesia management. After being placed in the prone position, patients will be warmed with heaters containing an air-blowing system during the operation to prevent hypothermia. Anesthesia will be maintained with total intravenous anesthesia as a controlled infusion. Rainbow sensors will be placed on the 4th fingertips of the non-dominant hand of the patients and connected to the Radical-7 Pulse CO-Oximeter device and the initial Hb value will be recorded routinely and recorded hourly during the operation. Hemogram samples will be studied in the laboratory. During the operation, every hour and at the end of the operation, SpHb value, Hb, Hct levels in hemogram will be recorded. At the end of the operation, the amount of intraoperative blood transfusion, the amount of crystalloid and colloid given, the duration of the operation, the duration of anesthesia, urine output, and the need for vasopressors will be routinely recorded. A database will be created in a computer environment from this information.
- Conditions
- Scoliosis Patients
- Being tested
- Radical-7 Pulse CO-Oximeter
- Keywords
- scoliosis, hemoglobin monitoring
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical-7 Pulse CO-OximeterDevice
Also called Hemogram samples
Rainbow sensors will be placed on the 4th fingertips of the non-dominant hand of the patients and connected to the Radical-7 Pulse CO-Oximeter device and the initial Hb value will be recorded routinely and recorded hourly during the operation. Hemogram samples will be studied in the laboratory. During the operation, every hour and at the end of the operation, SpHb value, Hb, Hct levels in hemogram will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis patients | Include patients who will undergo elective scoliosis surgery under general anesthesia. Receives: Device: Radical-7 Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hemoglobin (SpHb)
Total Hemoglobin will be recorded from the monitor
Measured: Before the anesthesia induction
Total Hemoglobin (SpHb)
Total Hemoglobin will be recorded from the monitor
Measured: 1 hour after the anesthesia induction
Total Hemoglobin (SpHb)
Total Hemoglobin will be recorded from the monitor
Measured: 2 hours after the anesthesia induction
Total Hemoglobin (SpHb)
Total Hemoglobin will be recorded from the monitor
Measured: 3 hours after the anesthesia induction
Total Hemoglobin (SpHb)
Total Hemoglobin will be recorded from the monitor
Measured: Through operation completion, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jul 2025
- Primary completion15 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erhan Ozyurt
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Erhan Ozyurt, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054411
- Sponsor's protocol ID
- CEMAL01
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shabaninejad H, Ghadimi N, Sayehmiri K, Hosseinifard H, Azarfarin R, Gorji HA. Comparison of invasive and noninvasive blood hemoglobin measurement in the operating room: a systematic review and meta-analysis. J Anesth. 2019 Jun;33(3):441-453. doi: 10.1007/s00540-019-02629-1. Epub 2019 Mar 20.
PubMed 30895376
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin Monitoring in Scoliosis Surgery: Comparison of Non-invasive and Invasive Methods
- ClinicalTrials.gov ID
- NCT07054411
- Acronym / sponsor ID
- CEMAL01
- Conditions
- Scoliosis Patients
- Keywords
- scoliosis, hemoglobin monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Erhan OzyurtOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is planned to include patients who will undergo elective scoliosis surgery under general anesthesia at the Health Sciences University Antalya Education and Research Hospital. Demographic data including age, gender, height, weight, and ASA score of the patients will be recorded before general anesthesia. ECG, oxygen saturation, and non-invasive blood pressure will be monitored while the patients are lying supine before general anesthesia. An esophageal temperature probe will be placed before being placed in the prone position. All patients will receive standard anesthesia management. After being placed in the prone position, patients will be warmed with heaters containing an air-blowing system during the operation to prevent hypothermia. Anesthesia will be maintained with total intravenous anesthesia as a controlled infusion. Rainbow sensors will be placed on the 4th fingertips of the non-dominant hand of the patients and connected to the Radical-7 Pulse CO-Oximeter device and the initial Hb value will be recorded routinely and recorded hourly during the operation. Hemogram samples will be studied in the laboratory. During the operation, every hour and at the end of the operation, SpHb value, Hb, Hct levels in hemogram will be recorded. At the end of the operation, the amount of intraoperative blood transfusion, the amount of crystalloid and colloid given, the duration of the operation, the duration of anesthesia, urine output, and the need for vasopressors will be routinely recorded. A database will be created in a computer environment from this information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis patients | – | Device: Radical-7 Pulse CO-OximeterInclude patients who will undergo elective scoliosis surgery under general anesthesia. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who apply to our hospital's orthopedic clinics to undergo elective scoliosis surgery.
Key inclusion criteria (2 listed)
- Preoperative hemoglobin ≥ 9 g/dL
- ASA I - III
Key exclusion criteria (2 listed)
- Patients with hematological disease,
- Uncorrected preoperative anemia (preoperative hemoglobin < 9 g/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical-7 Pulse CO-OximeterAlso: Hemogram samplesRainbow sensors will be placed on the 4th fingertips of the non-dominant hand of the patients and connected to the Radical-7 Pulse CO-Oximeter device and the initial Hb value will be recorded routinely and recorded hourly during the operation. Hemogram samples will be studied in the laboratory. During the operation, every hour and at the end of the operation, SpHb value, Hb, Hct levels in hemogram will be recorded. | Device | Scoliosis patients |
Primary outcome
Total Hemoglobin (SpHb)
Time frame: Before the anesthesia induction
Total Hemoglobin will be recorded from the monitor
Total Hemoglobin (SpHb)
Time frame: 1 hour after the anesthesia induction
Total Hemoglobin will be recorded from the monitor
Total Hemoglobin (SpHb)
Time frame: 2 hours after the anesthesia induction
Total Hemoglobin will be recorded from the monitor
Total Hemoglobin (SpHb)
Time frame: 3 hours after the anesthesia induction
Total Hemoglobin will be recorded from the monitor
Total Hemoglobin (SpHb)
Time frame: Through operation completion, an average of 4 hours
Total Hemoglobin will be recorded from the monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 30895376Shabaninejad H, Ghadimi N, Sayehmiri K, Hosseinifard H, Azarfarin R, Gorji HA. Comparison of invasive and noninvasive blood hemoglobin measurement in the operating room: a systematic review and meta-analysis. J Anesth. 2019 Jun;33(3):441-453. doi: 10.1007/s00540-019-02629-1. Epub 2019 Mar 20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Patients, run by Erhan Ozyurt at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Hemoglobin (SpHb) (time frame: Before the anesthesia induction). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.